Kornimate/medical-research-clean huggingface dataset:
efficacy of placebo versus chlorpheniramine for the prevention of allergic transfusion reactions.

Conditions: Allergic Transfusion Reaction

Summary: this is a prospective, randomized, double-blind controlled trial to evaluate the efficacy of placebo versus chlorpheniramine for the prevention of allergic transfusion reactions.


Eligibility criteria:
inclusion criteria: * 18\~65 years old. * subject is diagnosed with hematological disorder and requires blood product (i.e. suspended red blood cells, apheresis platelets, fresh frozen plasma) transfusions. * subject can fully understand and voluntarily sign informed consent forms. exclusion criteria: * subject with a history of allergic diseases. * subject experienced at least 1 moderate/severe or 2 mild allergic reactions in the past. * subject received glucocorticoid or allergy drugs within 24 hours before blood transfusion. * subject transfused with washed rbc. * received allo-hsct transplantation before. * subject with heart failure. * subject suffered from sequelae of cardiovascular or cerebrovascular diseases. * pregnant or nursing women. * inability to understand or to follow study procedures.

Keywords: pretransfusion medication chlorpheniramine blood transfusion allergic transfusion reaction
description of lactulose administration by balloon rectal tube in severe hepatic encephalopathy

Conditions: Hepatic Encephalopathy

Summary: acute liver failure in cirrhotic patients is associated with a one-month mortality of 48%. encephalopathy, largely related to hyperammonemia, is a frequent complication of liver failure and is a poor prognostic marker. lactulose decreases ammonia by acidification of the colon, replacement of urease-producing bacteria and creation of a laxative effect. thus, the administration of lactulose in patients with severe hepatic encephalopathy reduces mortality by more than 40%. in intensive care patients, lactulose is often administered rectally. the use of simple rectal tubes is associated with frequent leakage of lactulose as well as faecal discharge and therefore risks of infection and skin lesions. balloon rectal tubes with a drug delivery valve have recently been developed and used in this indication. the aim of this study is therefore to describe the use of these balloon rectal tubes to administer lactulose in severe hepatic encephalopathy. this suggests that ammonia reduction in these patients may prolong survival time. no studies have described the administration of lactulose via the rectal route with a balloon tube. the descriptive methodology is therefore appropriate. this is a preliminary study allowing data collection to establish the methodology for a subsequent clinical trial.


Eligibility criteria:
inclusion criteria: * \> 18 years * patients treated with lactulose with balloon rectal probe exclusion criteria: * patient(s) objecting to the use of their data for research purposes * rectal probe contraindication: damage to the rectal mucosa, rectal surgery, severe haemorrhoids, rectal stenosis, rectal tumour, * lactulose contraindication (person unable to absorb galactose) * patients deprived of liberty, under guardianship or curators * pregnant women * patient not affiliated to a social security scheme
sodium sensitivity in african americans

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension; Vascular Diseases

Summary: to compare the effects of two levels of dietary sodium on blood pressure in black men and women, and to determine what factors predict the degree of response.

background: the study permitted a more precise estimate of the effects of sodium chloride on blood pressure in blacks and a systematic examination of sodium sensitivity defined by various methods. the results had significance in answering questions about risk factors for blood pressure in blacks and for defining sodium sensitivity. design narrative: double-blind, two-period cross-over. all participants were given six weeks of intensive nutritional counseling to lower 24-hour urine sodium output from an estimated 165 meq/24 hours at baseline to less than 140 meq/24 hours. only those participants who excreted less than 140 meq /24 hours after six weeks of intensive dietary sodium intervention and had greater than 70 percent adherence to study capsules were eligible for randomization. eligible subjects were assigned to one of two treatment sequences: 100 meq of sodium chloride capsules per day during period one followed by placebo capsules during period two; placebo capsules during period one followed by 100 meq of sodium chloride capsules per day during period two. the major endpoint was change in diastolic and systolic blood pressure. a number of other measures were carried out, including blood chemistries, glucose tolerance (glucose and insulin), insulin resistance, urinary kallikrein, serum renin, and plasma norepinephrine. other major aims of the trial included testing general new diagnostic criteria for sodium sensitivity, examining predictors of sodium sensitivity, and examining how changes in sodium intake influenced change in specific metabolic parameters. the trial design incorporated careful control of the dietary changes and strict standardization of blood pressure measurement with a random-zero device. the study was extended through june 1997 on fy 1995 funds.

Eligibility criteria:
no eligibility criteria
gs-6615 in adults with chronic stable angina and coronary artery disease

Conditions: Ischemic Heart Disease

Summary: this study will evaluate the effect of gs-6615 in adults with chronic stable angina and coronary artery disease (cad) receiving a stable daily dose of up to 2 antianginal medications. the study will consist of two periods: a 1 to 3 week qualifying period and a treatment period lasting 13 days (± 3 days). during the qualifying period and at the end of the treatment period, participants will undergo exercise tolerance testing.


Eligibility criteria:
inclusion criteria: * able to perform a standardized treadmill exercise protocol * at least a 3 month history of chronic stable angina triggered by physical effort and relieved by rest and/or short-acting nitroglycerin * coronary artery disease (cad) documented by one or more of the following: * angiographic evidence (either invasive or noninvasive) of ≥ 50% stenosis of one or more major coronary arteries * history of myocardial infarction (mi) documented by positive creatine kinase-myocardial band (ck-mb) enzymes, troponins, or electrocardiogram (ecg) changes * noninvasive imaging stress test diagnostic of cad (eg, nuclear perfusion scan, stress echocardiogram, stress cardiac magnetic resonance scan) * stable antianginal treatment with up to 2 antianginal agents exclusion criteria: * inability to exercise or having exercise limitation due to other co-morbidities that may interfere with ability to perform required exercise tolerance testing (ett) * presence of electrocardiographic or other abnormalities that interfere with ecg interpretation or may cause a false positive stress test * history of heart failure as defined by new york heart association class iii-iv and/or known left ventricular ejection fraction ≤ 45% * history of severe disabling angina as defined by canadian cardiovascular society class iv * myocardial infarction, acute coronary syndrome or coronary revascularization within 3 months prior to screening, or planned coronary revascularization during the study period * stroke or transient ischemic attack within 6 months prior to screening * chronic persistent atrial fibrillation * uncontrolled hypertension (seated systolic blood pressure (sbp) \> 160 mm hg or diastolic blood pressure (dbp) \> 110 mm hg) * body mass index (bmi) ≥ 36 kg/m\^2

Keywords: gs-6615 coronary heart disease angina pectoris late sodium current myocardial ischemia coronary artery disease chronic stable angina
ipad as a distraction tool during facial laceration repair

Conditions: Anxiety; Laceration Repair; Children

Summary: children aged 2-12 presenting to the rady children's hospital san diego (rchsd) emergency department with facial lacerations requiring suture repair will be eligible to participate in the study. participating children will be randomized to standard care versus standard care plus ipad use during the procedure. children's anxiety levels assessed using a validated scale will be measured from video recordings made of the procedure. parent and provider satisfaction surveys will be completed following the procedure. the primary study aim is to determine how ipad use affects children's anxiety levels during facial laceration repair. the secondary study aim is to determine how ipad use affects parent and provider satisfaction regarding a child's facial laceration repair. hypothesis is that ipad use decreases children's anxiety levels during facial laceration repair and increases parent and provider satisfaction regarding a child's facial laceration repair.


Eligibility criteria:
inclusion criteria: 1. patients: male and female children aged 2-12 of all ethnic backgrounds and socioeconomic levels presenting to the emergency department for laceration repair. children sustaining single, uncomplicated facial lacerations, which can be repaired with basic suture techniques, are eligible for the study. lacerations repaired using let cream, lidocaine injection, and let cream and lidocaine injection are all eligible for the study. 2. parents of enrolled patients. 3. providers of enrolled patients: residents, fellows, attendings, and nurse practitioners serving as the primary provider performing the laceration repair. exclusion criteria: 1. patients: lacerations to parts of the body other than the face. children with developmental disabilities. children with laceration repair requiring sedation. children with complex lacerations requiring subspecialty repair. 2. parents and/or providers of children not eligible or enrolled in the study. 3. providers: medical students performing the laceration repair.
intensified treatment with carfilzomib in myeloma patients still pet-positive after first line treatment.

Conditions: Myeloma

Summary: a pet-ct will be performed on patients with myeloma after a standard first-line treatment. the pet-positive patients will receive 4 cycles of carfilzomb-revlimid-dexamethason (krd), before a new pet-ct will be performed.

patients will be evaluated for inclusion after finishing first-line therapy, or after a sufficient amount of treatment in first-line, and a sufficient respons (vgpr). eligible performed regimens are defined in the protocol. all patients will perform a pet-ct, and pet-negative patients will be excluded from protocol treatment. the pet-positive patients will do a minimal residual disease (mrd-)evaluation in the bone marrow before entering treatment. after 4 28day cycles of carfilzomib-revlimid-dexamethason, a new mrd and a new pet-ct will be performed, as measures of outcome. patients will continue treatment as written in the protocol.

Eligibility criteria:
inclusion criteria: 1. prior confirmed diagnosis of multiple myeloma (2014). 2. received standard first line treatment with at least partial response. standard first line treatment is defined as * vrd, vtd or vcd followed by asct, or * mpv at least 6 cycles, or no further reduction in monoclonal component the last 2 cycles, or * rd at least 9 cycles or no further reduction in monoclonal component the last 2 cycles. 3. carfilzomib naïve. 4. eastern cooperative oncology group (ecog) performance status 0-2. 5. absolute neutrophil count (anc) ≥ 0,5 x 109/l) and platelet count \>35 x 109/l. 6. at least very good partial remission (vgpr) from first line treatment exclusion criteria: 1. change of first line treatment because of stabile or progressive disease. 2. major surgery within 28 days before enrollment. 3. radiotherapy within 14 days before enrollment, but if the involved field is small, 7 days will be considered a sufficient interval before onset of the treatment. 4. glucocorticoid therapy within the 14 days prior to inclusion that exceeds a cumulative dose of 160 mg dexamethasone or 1000 mg prednisone. 5. central nervous system involvement. 6. uncontrolled heart disease, including congestive heart failure (nyha iii-iv), uncontrolled angina pectoris, uncontrolled conduction abnormalities, acute diffuse infiltrative pulmonary disease, pericardial disease or myocardial infarction within 6 months prior to enrollment 7. uncontrolled hypertension or uncontrolled diabetes despite medication 8. active hepatitis b or c infection or known human immunodeficiency virus (hiv) positivity. 9. another active malignancy. patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. 10. primary plasma cell leukemia, systemic al amyloidosis, waldenströms macroglobulinemia, poems syndrome
genetic variation in platelet aggregation

Conditions: Myocardial Infarction

Summary: the aim of the study is to test whether genetic variation in the alpha 2a adrenergic receptor affects diurnal variation in platelet aggregation.

there is a marked diurnal fluctuation in the occurrence of acute myocardial infarction and sudden death, with peak incidences occurring in the early morning. platelet aggregation has also been shown to increase in the early morning. the investigators will test the hypothesis that alpha 2a-adrenergic receptor (adra2a) genetic variation, specifically haplotype 4, affects platelet aggregation. the investigators will compare diurnal platelet aggregation in haplotype 4 subjects with subjects in the other haplotype families. in addition, the investigators will compare platelet aggregation after the cold pressor test in haplotype 4 with the other haplotype families. if there are no differences among haplotypes, then the haplotypes will be combined to analyze.

Eligibility criteria:
inclusion criteria: * men and women aged 18 - 45 years inclusive. * women of the above age will be studied between day 1 and day 14 of a normal menstrual cycle. * subjects must be willing to give informed consent for the study and able to adhere to the study diet and study procedures. * subjects and immediate extended family up till grandparents will be caucasians or african americans only. * subjects will be free of any clinically significant disease. * clinical laboratory test (cbc, blood chemistry) will be within acceptable limits. exclusion criteria: * subjects who have taken any antiplatelet, anticoagulant or procoagulant medicines within the last three weeks preceding the study. * subjects who have taken medications (including over the counter medications) other than oral contraceptives in the past two weeks. * subjects who smoke or have smoked in the past 3 months. * subjects who are presently or were formerly a narcotic addict or alcoholic. * females with a positive pregnancy test. * females who are breast feeding.

Keywords: myocardial infarction platelet aggregation cold pressor test genetics
evaluation of the effects of different interventions on glycemic control in newly-diagnosed type 2 diabetic patients

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to investigate and evaluate the effects of different interventions (1.continuous subcutaneous insulin infusion,2.multiple daily injections, 3.anti-hyperglycemic agents) on glycemic control, b-cell function and the remission rate in newly-diagnosed type 2 diabetic patients.

ß-cell dysfunction and decreased insulin sensitivity are the main pathophysiological defects responsible for the development of hyperglycemia. with continuous presence of insulin resistance, progressive loss of ß-cell function is the crucial defect. hyperglycemia has deleterious effect on β-cell function, which is partially reversible by adequate glycemic control. in newly diagnosed type 2 diabetic patients with severe hyperglycemia, 2 weeks continuous subcutaneous insulin infusion (csii) can induce adequate glycemic control with improvement of β-cell function. nearly half of the patients can maintain euglycemia longer than 12 months by transient csii. the improvement of β-cell function, especially the restoration of the first-phase insulin response is related to sustained euglycemia in the newly diagnosed type 2 diabetic patients. but it is unclear whether any other interventions (such as oral hypoglycemic agents and multiple daily injections) inducing optimal glycemic control in a short period of time can have the same effect. as a multicenter, open-label, randomized, parallel-group study will be needed to further prove and clarify the findings.

Eligibility criteria:
inclusion criteria: 1. informed consents be given before treatment 2. the newly-diagnosed type 2 diabetic patients 3. fasting blood glucose (fbg) level ranging from 7.0～16.7 mmol/l 4. age ranging from 25～70 years old 5. body mass index (bmi) ranging from20～35kg/m2 6. never be treated with any anti-hyperglycemic agents or anti-hyperlipidemic agents exclusion criteria: 1. having any severe acute or chronic complications 2. renal dysfunction, blood creatinine≥150µmol/l 3. blood aminotransferase level rising up(more than 2 times of the normal level) 4. any severe cardiac disease including congestive cardiac failure, unstable angina and myocardial infarct in 12 months 5. serious hypertension (systolic pressure≥180mmhg and/ or diastolic pressure≥110mmhg) 6. chronic or acute pancreatic disease 7. severe systematic diseases or malignant tumor 8. allergic to the drugs using in the trial 9. any factors interfering the result 10. female patients incline to be pregnant 11. being treated with corticosteroid, immunosuppressing drugs or cytotoxic drugs 12. poor compliance

Keywords: type 2 diabetes mellitus therapy sulfonylureas metformin insulin
pulmonary evaluation with ultrasound in different levels of peep

Conditions: Atelectasis; Hypertension; Lung Edema

Summary: patients submitted to general anesthesia and artificial ventilation almost always develop pulmonary atelectasis, which can determine adverse consequences both intraoperatively and postoperatively. it is recommended to use physiological tidal volume (6 - 8 ml / kg of ideal body weight) during the intraoperative period in order to minimize the risk of lung injury. to prevent the formation of atelectasis, minimizing the risk of complications, the use of peep has been recommended. at present, there is no way to make an optimal adjustment of peep to the needs of each patient, seeking a value that keeps the alveoli open without forming atelectasis and also without areas of hyperdistension. the aim of this study was to evaluate the agreement between the ultrasound and the electrical impedance tomography - timpel® (tie) to detect the beginning of the formation of areas of atelectasis after pulmonary recruitment, with decreasing peep values. in addition, the lung ultrasound will be validated for intraoperative use for both adequacy of peep, as well as quantitative analyzes of ultrasound images to assess atelectasis. 18 patients (\> 18 years) of both sexes, submitted to general anesthesia, will be prospectively studied. all patients will receive, in addition to the usual monitoring, the monitoring with the electrical impedance tomography and chest ultrasonography, after being anesthetized and under neuromuscular block, being ventilated with an inspired fraction of 50% oxygen (or greater to maintain oxygen saturation \> 96% ), tidal volume of 6 ml / kg and respiratory rate to maintain expiratory tidal co2 between 35-45 cmh2o.


Eligibility criteria:
inclusion criteria: * participants will be male and female patients, over 18 years of age, who undergo abdominal surgeries (prostatectomies and hysterectomies) and who do not have preexisting pulmonary diseases. they will be approached in the room prior to surgery, at which time the purpose of the research will be explained, besides making clear that it will not entail costs and so little any injury, scar, or damage. if accepted by the patient, the consent form will be applied. exclusion criteria: * exclusion criteria for the study will be: patients classified by the american society of anesthesiologists physical status as asa-3 or above, patients with obstructive and restrictive respiratory diseases, patients with predictable orotracheal intubation difficulties (eg, obese patients) who require manipulation of the upper airways. also excluded are patients with pacemakers and patients scheduled for procedures in the thoracic region
arterial cannulation with ultrasound

Conditions: Perioperative/Postoperative Complications

Summary: a drop in blood pressure during anaesthesia for a surgical procedure has been associated with worse patient outcomes, including complications such as damage to the heart, brain and kidneys. continuous blood pressure monitoring prior to the start of anaesthesia alerts the anaesthetist to drops in blood pressure and allows this to be treated promptly. this may help to avoid the complications described above. continuous blood pressure monitoring is carried out by inserting a small plastic tube (cannula) into an artery. in this study, the investigators propose inserting a cannula into the radial artery in the wrist before a patient is anaesthetised for surgery. the usual technique for insertion of this cannula is for the anaesthetist to identify the site of the radial artery by feeling for an arterial pulse with the fingertips (palpation). an alternative technique for identification is to use ultrasound. ultrasound creates a two-dimensional image of the area under the skin on a screen, enabling the operator to visualise the artery being targeted. this may reduce the number of cannulation attempts required, reducing patient discomfort.

the investigators will test whether ultrasound guidance improves the success rate of radial artery cannulation, compared to palpation alone, in a randomised controlled trial in an nhs hospital. patients will be over 45 years old, undergoing general or neuraxial anaesthesia for non-cardiac surgery lasting 120 minutes or more. patients will be randomly assigned to a palpation or ultrasound-guided technique for arterial cannulation. patients will receive numbing local anaesthetic cream to the area beforehand. a needle is used to introduce the cannula into the artery. there will be a maximum of one attempt allowed. in addition to measuring success rate, we will also compare whether the successfully sited cannula provides an adequate arterial waveform, requires resiting at any point during the surgery and any complications which arise directly related to arterial catheterisation. patients will receive standard anaesthetic and surgical care in all other respects.

Eligibility criteria:
inclusion criteria: 1. patients scheduled to undergo major elective or urgent (not requiring intervention in \ 120 minutes from induction of anaesthesia 2. requiring overnight hospital stay. exclusion criteria: 1. anatomical deformity 2. unable to consent 3. cannulation attempt within 24 hours 4. overlying infection

Keywords: arterial cannulation ultrasound